A Phase II Study of Neoadjuvant Immunotherapy in Combination With Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLei Liu
About this trial
A Randomized, Phase II Study of ivonescimab or cadonilimab or penpulimab in Combination With Cisplatin and Nab-paclitaxel in Patients With locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection.
This proposed study will evaluate the efficacy and safety of preoperative administration of ivonescimab or cadonilimab or penpulimab combined with chemotherapy in HNSCC who are eligible for resection.
Eligibility criteria
Qualifiers
Males and females； Age：18 to 75 years.
Histologically or cytologically confirmed head and neck squamous cell carcinoma (HNSCC).
Patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Disqualifiers
Patients who have received any form of anti-tumor treatment previously.
Patients with allergic constitution and congenital immune deficiencies.
Patients who have undergone organ transplantation.
Patients with a history of severe bleeding tendencies or coagulation dysfunction; those who have had clinically significant bleeding symptoms within 1 month prior to the study treatment, including but not limited to gastrointestinal bleeding, hemoptysis; those who have received prolonged anticoagulation treatment within 10 days prior to the study treatment.
Trial design
Treatments tested in this trial
- Ivonescimab combined with TP
- Cadonilimab combined with TP
- Penpulimab combined with TP
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Lei Liu
Lead sponsor
West China Hospital
Sponsor institution
Source ClinicalTrials.gov